Coronavirus (COVID-19) Update: December 1, 2020

The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:

• The FDA has reissued the August 23, 2020 emergency use authorization (EUA) for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.
• As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Avazo-Healthcare, LLC for selling adulterated and misbranded COVID-19 test kits and unapproved drug products with fraudulent COVID-19 claims. In addition to COVID-19 test kits, the company sells CBD products with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA requested that Avazo-Healthcare immediately stop selling these unapproved, uncleared and unauthorized test kits and unapproved products. Consumers concerned about COVID-19 should consult with their health care provider.
• The FDA has also posted the following warning letters for unapproved and misbranded products related to COVID-19: ChromaDex; Innovative Medicine LLC; Red Moon Herbs; Sage Woman Herbs, Ltd. dba Sage Consulting & Apothecary.

• Further, the FDA has updated the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency. The update is intended to further assist manufacturers in providing the FDA with timely and informative notifications about changes in the production of certain medical devices that could help the FDA prevent or mitigate shortages of such devices during the COVID-19 public health emergency. The FDA updated this guidance to:
  • Clarify factors the FDA considers in determining:
    • whether a device is in shortage,
    • how shortage assessments inform FDA work to help address the public health emergency, and
    • what information the FDA includes in the publicly-available list of medical devices the FDA has determined to be in shortage;
  • Provide information regarding letters for failure to notify the FDA pursuant to section 506J(e) of the FD&C Act;
  • Provide information about prioritizing and expediting inspections and premarket reviews to help mitigate and prevent shortages; and
  • Revise the recommended timeline for updates to 506J notifications from two weeks to six weeks.
• Testing updates:
  • As of Dec. 1, 295 tests are authorized by FDA under EUAs; these include 227 molecular tests, 61 antibody tests, and 7 antigen tests.